Edwards Lifesciences Corporation

Applied Medical Resources Corporation

Cianna Medical, Inc.

Sub-q, Incorporated

Robert R Bowes

David Mark Taylor

John R Brustad

Philippe Marchand

Ronaldo C Cayabyab

Richard Christian Ewers

Nabil Hilal

Edward D Pingleton

David J Evans

Payam Adlparvar

Gary R Dulak

Christopher Chia

Robert Milich

Charles C Hart

Thanh Huy Le

Gary M Johnson

Jeremy J Albrecht

Donald L Gadberry

Henry Kahle

Eric Nguyen

Ghassan Sakakine

Larry L Wood

Hamid Rafi

Uy D Trinh

Scott V Taylor

Tri D Tran

Michael J Dunn

Norman L Morales

Antonio O Vidal

Emil Karapetian

Tung Thanh Le

Gregory I Bak-Boychuk

Russell Thomas Joseph

Sonny Tran

Brian C Gray

Maria Lillian Saravia

Alejandro J Froimovich Rosenberg

Andrew Oien

Eduardo Chi Sing

Ismail Thazhapilavil

Jacob White Sullivan

Matthew Paul Dwight

George D Hermann

Mark Philip Ashby

Gail S Lebovic

Doug Sutton

Luis Urquidi

Andrew M Cragg

Vincent C Tangherlini

Russ Hunton

Tom Furey

Cradle

A method for deploying an expandable prosthetic heart valve in a patient includes introducing a guidewire into a patient and advancing the guidewire through a vasculature of a patient to a deployment site. A distal end portion of a delivery apparatus and the prosthetic heart valve mounted in a radially compressed configuration along the distal end portion are advanced over the guidewire. The prosthetic heart valve is positioned at the deployment site. A screw mechanism is rotated, which exerts an axially directed onto the prosthetic heart valve, causing the prosthetic heart valve to radially expand from the radially compressed configuration to a radially expanded configuration.

Method for deploying a prosthetic heart valve

Assemblies and delivery apparatus for delivering a medical device into a patient's vasculature are disclosed. In some examples, an assembly includes a delivery apparatus and a radially compressible and expandable prosthetic heart valve. The delivery apparatus includes a handle, a first shaft and a second shaft extending from the handle, and a locking mechanism to prevent axial movement of the second shaft relative to first shaft. The second shaft extends coaxially through the first shaft and includes, at a distal end portion thereof, a balloon, one or more radiopaque markers, and the prosthetic valve radially compressed over the balloon. A flared end piece extending from the first shaft covers a proximal portion of the balloon during advancing of the delivery apparatus through a patient's vasculature. The first shaft is retractable relative to the second shaft to expose the balloon from the flared end piece.

Delivery apparatus for prosthetic heart valve

Disclosed embodiments of introducer devices provide hemostatic sealing and allow a delivery catheter to be inserted through the introducer seals without the use of a separate loader device that covers a medical device that is mounted on the catheter. Some disclosed introducers comprise a housing, a distal sheath extending distally from the housing and adapted to be inserted into a patient's vasculature, a distal hemostatic seal mounted within the housing and a proximal hemostatic seal mounted within the housing, and a slidable tube positioned within the housing that is movable longitudinally relative to the distal hemostatic seal between a proximal position and a distal position, wherein in the proximal position a distal end of the tube is positioned proximal to the distal hemostatic seal with the distal hemostatic seal closed, and wherein in the distal position the distal end of the tube extends through the distal hemostatic seal.

Intravascular introducer devices

Embodiments of the present disclosure provide an introducer device and methods for introducing a medical device into a patient's vasculature. In one embodiment, a method of using an introducer device including a housing, a hemostatic seal mounted within the housing, and a tube extending into the housing and movable longitudinally relative to the hemostatic seal between a proximal position and a distal position, includes moving the tube to the distal position such that the distal end of the tube extends through the hemostatic seal. The method further includes inserting a distal end portion of the medical device through the tube and into the patient's vasculature without contacting the hemostatic seal.

Introducer device for medical procedures

Pinch devices and access systems that can be used to secure a prosthetic heart valve to a heart valve annulus and to treat valvular insufficiency. A pinch device can be a separate expandable element from the prosthetic heart valve that is first advanced to the annulus and deployed, after which an expandable prosthetic heart valve can be advanced to within the annulus and deployed. The two elements can clamp/pinch the heart valve leaflets to hold the prosthetic heart valve in place. The pinch device can have a flexible, expandable annular frame. A combined delivery system can deliver the pinch device and prosthetic heart valve with just a single access point and aid more accurate coaxial deployment. The pinch device can be mounted near distal end of an access sheath, and a catheter for delivering the prosthetic heart valve can be passed through a lumen of the same access sheath.

Heart valve pinch devices and delivery systems

A method for replacing a stenotic native aortic valve of a patient can include inserting a delivery apparatus into a femoral artery of the patient, the delivery apparatus having a first shaft extending from the handle, a second shaft disposed around the first shaft, a third shaft extending through the second shaft, and a valve cover coupled to the first shaft. The valve cover can be in a first state housing an entirety of a prosthetic heart valve and retaining the prosthetic heart valve in a radially compressed state during the act of inserting. The method can further include advancing the delivery apparatus through the aorta of the patient to position the valve cover and the prosthetic heart valve within the native aortic valve, and moving the valve cover longitudinally from the first state to a second state in which the entirety of the prosthetic heart valve is uncovered.

Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed delivery apparatuses can include a handle, a first shaft extending from the handle, a second shaft disposed around the first shaft, and a valve cover. The valve cover can be coupled to a distal end portion of the first shaft and can be configured to house a prosthetic heart valve in a radially compressed state. The valve cover can have an outer diameter greater than an outer diameter of the second shaft, and the first shaft and valve cover can be movable together in an axial direction relative to the second shaft.

Embodiments of the present disclosure provide an introducer device for introducing a medical device into a patient's vasculature. In one embodiment, the introducer device comprises a housing, a distal sheath adapted to be inserted into a patient's vasculature with the housing positioned outside of the patient's vasculature, a hemostatic seal mounted within the housing, and a tube positioned within the housing and movable longitudinally relative to the hemostatic seal between a proximal position and a distal position. In the proximal position, a distal end of the tube is positioned proximal to the hemostatic seal with the hemostatic seal closed. In the distal position, the distal end of the tube extends through the hemostatic seal and permits the medical device to be inserted through the housing and into the patient's vasculature without contacting the hemostatic seal.

Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed steerable catheters can include a handle, a steerable shaft extending from the handle, and a pull wire. The shaft can include a main lumen, an inner polymeric layer surrounding the main lumen, a braided layer surrounding the inner polymeric layer, and an outer polymeric layer surrounding the braided layer, the outer polymeric layer defining a pull wire lumen. The pull wire can extend from the handle and through the pull wire lumen and can have a distal end portion coupled to a distal end portion of the shaft.

Embodiments of the present disclosure provide an introducer device and method for introducing a delivery apparatus into a patient's vasculature. Disclosed methods can include positioning a sleeve of an introducer sheath in a blood vessel of a patient, the sleeve having a lattice layer with a lumen therethrough, inserting a distal end portion of the delivery apparatus and a prosthetic heart valve into the lumen, and advancing the distal end portion of the delivery apparatus through the lumen from the proximal end to the distal end. The method can then include expanding the lumen from a first diameter smaller to a second diameter at least equal to the diameter of the prosthetic heart valve to allow passage of the prosthetic heart valve through the lumen, and returning the lumen of the sleeve to a diameter smaller than the second diameter after advancing the prosthetic heart valve through the lumen.

Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed delivery apparatuses can include a housing, a steerable shaft, a slide nut, and a threaded shaft disposed over the slide nut. The slide nut can have an external threaded surface and an internal surface comprising a slot. The threaded shaft can have an internal threaded surface engaging the external threaded surface of the slide nut. The delivery apparatus can further include an elongated nut guide extending into the slot of the nut to restrain the slide nut against rotation relative to the housing, and a pull wire having a proximal end portion extending into the housing and coupled to the slide nut, and a distal end portion coupled to a distal end portion of the steerable shaft. The threaded shaft can be rotatable relative to the housing to produce axial movement of the slide nut within the threaded shaft.

Growing community of inventors

Aliso Viejo, CA, United States of America

Robert R Bowes